MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT®; STENT, CAROTID

Model Number M001719020

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2014.It was reported that difficulty tracking over wire occurred.A 8x29, 5f, 135cm carotid wallstent® was advanced over a 0.014 guide wire however a lot of resistance was encountered and the guide wire did not come out at the rx port.The device never entered the patient's body.The procedure was completed using a different device no patient complications were reported.However, returned device analysis revealed a foreign matter on the device.

Manufacturer Narrative

Device evaluated by mfr: the stent of the device was received fully mounted onto the stent delivery system.Traces of blood were visible in the guidewire lumen indicating an attempt had been made to advance this device over the guidewire.A visual and tactile examination found no kinks or damage along the shaft of the device.An attempt to insert a 0.014 inches guidewire through this device however an obstruction was encountered 1mm distal to the guidewire exchange port which was preventing the guidewire from exiting.Traces of blood were noted throughout the guidewire lumen and the obstruction appeared to be congealed blood.The device was left in a heated waterbath for 20 minutes to remove the obstruction.Upon further analysis the obstruction was manually removed using a mandrel.The obstruction was unraveled and measured approximately 2mm in length.A microscopic examination revealed that the material was fibrous and blue in color.A guidewire was then inserted through this device without issue.A review was then carried to determine the source of the blue foreign matter (fm).The review was unable to identify a comparable material to the fm sample found within the complaint device.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

• Brand Name: CAROTID WALLSTENT®
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4328914
• MDR Text Key: 18637156
• Report Number: 2134265-2014-07724
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2015
• Device Model Number: M001719020
• Device Catalogue Number: 71-902
• Device Lot Number: 0015036491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: 0.014 WIRE